Effects of Vestibular Rehabilitation on Balance and Post Stroke Fatigue :

NCT ID: NCT06673771

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-03-21

Brief Summary

The objective of the study is to determine the effects of stroke conventional therapy compared with the effects of vestibular rehabilitation therapy on balance and post stroke fatigue. The study will be randomized control trial including 2 experimental groups with estimated 28 individual in each group

Detailed Description

Stroke is the sudden onset of neurological disorders caused by damage to the cerebrovascular arteries. Vascular injury to the brain can be caused by rapid changes in blood pressure and oxygen shortage, resulting in the death of brain cells. Ischemia accounts for 80% of all strokes. Every year, 15 million individuals worldwide suffer from strokes, and five million become permanently disabled. Stroke prevalence is 1.2% in the province of KPK. Over the last 30 years, the burden caused by stroke has significantly increased, and it has become one of the most common causes of mortality globally. . The central nervous system's sensory (visual, vestibular, somatosensory) and motor systems work together to maintain balance. Patients who have had a stroke are more likely to fall than healthy people due to a variety of impairments in motor and cognitive processes. Vestibular dysfunction may potentially cause falls in this patient population due to poor postural control. It has been found that post stroke patients are more prone than healthy controls to lose standing postural stability under vestibular stimulation. Fatigue is a common post stroke consequence, with a prevalence of between 16 to 74% , and it is considered one of the signs of post stroke depression. However, the fact that patients without depression often complain of fatigue needs a study of "post stroke fatigue" (PSF) as a specific syndrome. This type of fatigue is chronic which can be the only symptom in stroke patients even with adequate neurologic recovery and persists for many years .Fatigue constitutes one of the most common symptoms after a stroke and an important predictor for mortality following stroke. PSF correlates with functional limitations and participation limitations in activities of daily living (ADL), leading to a lower quality of life. Vestibular functions requiring central integration correlate more strongly with fatigue, balance, and walking capacity. Stroke patients have shown an improvement in gait performance, balance, and self-perceived health with vestibular rehabilitation. It has been demonstrated that vestibular therapy has greater benefits on gait in stroke patients. Vestibular rehabilitation therapy (VRT) promote gaze stability, improve postural stability and facilitate sensory integration for patients. VRT was found to be beneficial for improving balance in patients with peripheral vestibular impairment. Cawthorne and Cooksey Exercise Program refers to Vestibular Rehabilitation Therapy. They are exercises that gradually train the eye and body muscles to use visual and proprioceptive signals to compensate for missing or disturbed vestibular signals (which cause poor balance and coordination).Gaze stabilization exercises (GSEs), a type of vestibular therapy, including substitution and adaptation exercises that use the vestibulo-ocular reflex (VOR). Substitution exercises are designed to promote different approaches (saccadic eye movement and smooth tracking activities) to compensate for inadequate vestibular function. Adaptation exercises are long-term alterations in the neural response to head motions that aim to reduce symptoms and normalize gaze and postural stability. GSEs can improve the balance function, confidence, and cognition in older adults with mild cognitive dysfunction .VOR gain has a certain effect on the balance and posture of people following stroke. Balance is common consequence among post stroke patients and increase the risk of fall. The central nervous system's sensory (visual, vestibular, somatosensory) and motor systems work together to maintain balance and prevalence of post stroke fatigue is between 16 to 74% which is high and also the Vestibular functions having highly significant relation with fatigue, and balance and limited evidence on vestibular rehabilitation on post stroke fatigue. That's why this study aims to assess the effect of vestibular rehabilitation training on balance and post-stroke fatigue

Conditions

Stroke Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vestibular Rehabiliation Therapy

VRT include head and body movemnt, eye movement, balance training

Group Type: EXPERIMENTAL

Vestibular Rehabiliation Therapy

Intervention Type: OTHER

Moving the eye horizontally between two stationary target while keeping the head still Moving the eye vertically between two stationary target while keeping the head still Moving the target horizontally and tracking it with the eye while keeping the head still Moving the target vertically and tracking it with the eye while keeping the head still Moving the head horizontally while a keeping a look on stationary target Moving the head vertically while a keeping a look on stationary target Moving the head and target in opposite direction horizontally while tracking the target with eyes Moving the head and target in opposite direction vertically while tracking the target with eyes.

Sit down and stand up, sit down and stand up with eye open and eye close Stand up, but turn to the right while standing Stand up, but turn to the left while standing Place an object on the floor. Take it and bring it above your head and place it on the floor again

Conventional Treatment

conventional treatment include balance, walking, weight shifting and muscle strengthening training

Group Type: ACTIVE_COMPARATOR

Conventional treatment

Intervention Type: OTHER

Standing balance training, weight shifting training, walking training, muscle strength training, step-up-and-down training.

Interventions

Vestibular Rehabiliation Therapy

Moving the eye horizontally between two stationary target while keeping the head still Moving the eye vertically between two stationary target while keeping the head still Moving the target horizontally and tracking it with the eye while keeping the head still Moving the target vertically and tracking it with the eye while keeping the head still Moving the head horizontally while a keeping a look on stationary target Moving the head vertically while a keeping a look on stationary target Moving the head and target in opposite direction horizontally while tracking the target with eyes Moving the head and target in opposite direction vertically while tracking the target with eyes.

Sit down and stand up, sit down and stand up with eye open and eye close Stand up, but turn to the right while standing Stand up, but turn to the left while standing Place an object on the floor. Take it and bring it above your head and place it on the floor again

Intervention Type: OTHER

Conventional treatment

Standing balance training, weight shifting training, walking training, muscle strength training, step-up-and-down training.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient diagnosed with stroke.
• Ability to stand for at least 1 minute without support.
• Fatigue Assessment Scale (FAS) score ≥ 24.
• Willingness to participate

Exclusion Criteria

• Cognitive Impairment.
• Severe unilateral spatial neglect.
• Severe aphasia.
• Patients who are not willing.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nadia Azhar MS-NMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Helping Hand Institute of rehabilitation

Mānsehra, Khyber Pakhtunkhuwa, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Nadia Azhar MS-NMPT

Role: CONTACT

Nadia.azhar@riphah.edu.pk

+923335281431

Facility Contacts

Nadia MS-NMPT

Role: primary

Nadia.azhar@riphah.edu.pk

Other Identifiers

Zil-e-huma

Identifier Type: -

Identifier Source: org_study_id